Dental Implants, Immediate Dental Implant Placement, Soft Tissue, Tooth Loss
Conditions
Keywords
Dental implant, Immediate implants, Custom Abutment, Sealing Socket Abutment
Brief summary
The aim is to clinically evaluate the effect of the alveolar sealing technique using a customised abutment on soft tissue volume changes following molar extraction and immediate dental implant placement. Thirty patients in ASA I-II health status who require immediate post-extraction implant treatment in the molar area were recruited after giving their informed consent, and were randomly allocated to two parallel groups (customised abutment vs. conventional abutment). The randomisation list was generated with the List Randomizer tool (Random.org), and allocation was performed by a secretary external to the research team after implant placement. The soft tissue status is recorded before and 6 months after treatment by means of a digital impression taken with the same intraoral scanner. The patient completes a 7-question questionnaire on their perception of the therapeutic process and the final result. A comparative volume measurement is made by digitally superimposing the two mesh files obtained before and 6 months after treatment. Digital models are anonymised and measured by an independent outcome assessor blinded to group allocation. Statistical data are analysed by an external statistician.
Detailed description
Thirty patients in ASA I-II health status requiring immediate post-extraction implant treatment in the molar area were recruited after informed consent and randomly allocated to two parallel groups: an experimental group receiving a customised sealing abutment and a control group receiving a conventional abutment, both after immediate implant placement. The randomisation list was generated with the List Randomizer tool (Random.org), and group allocation was performed by a secretary external to the research team after implant placement, ensuring allocation concealment. Soft tissue status is recorded before and 6 months after treatment using a digital impression taken with the same intraoral scanner (Medit i700). Patients complete a 7-question questionnaire on their perception of the therapeutic process and outcome. Volumetric change is measured by digitally superimposing the mesh files obtained before and 6 months after treatment. Digital models are anonymised and coded, and measured by an independent outcome assessor blinded to group allocation. Statistical analysis is performed by an external statistician.
Interventions
PROCEDUREImmediate dental implant placement
Placement of one dental implant immediately after tooth extraction.
Sponsors
Aula Dental Avanzada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor measured anonymized, coded digital models (STL files) and was blinded to group allocation during measurement.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ASA I or ASA II health status * Age between 18 and 80 years * Presence of a molar with poor restorative prognosis requiring extraction and immediate post-extraction implant placement
Exclusion criteria
* Psychiatric conditions or any condition preventing the patient from adequately completing the questionnaire * Teeth with periodontal involvement and loss of attachment caused by root fracture * Alveolus with bone deficiencies where an immediate implant cannot be adequately placed * Medical conditions contraindicating dental implant placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft tissue dimensional changes | From 0 to 6 months | The changes that occur in the soft tissues in millimetres by comparing the digital impressions before and 6 months after the treatment using specific software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients satisfaction | From 0 to 6 months | Patients will be asked about their satisfaction after the treatment in a Numerical Rate Scale form 0 (Not satisfied) to 10 (Very satisfied). |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORGuillem Esteve-Pardo, PhD
Clinica Dental Esteve
Outcome results
None listed